LEAD MODEL 302
Report
- Report Number
- 1644487-2012-01987
- Event Type
- Malfunction
- Date Received
- August 8, 2012
- Date of Event
- April 1, 2012
- Report Date
- July 16, 2012
- Manufacturer
- CYBERONICS, INC.
- Product Code
- LYJ
- PMA / PMN Number
- P970003
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.
DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED LEAD MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION.
DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.
ON (B)(6) 2012, A VNS TREATING PHYSICIAN REPORTED THAT HIGH IMPEDANCE WAS OBSERVED DURING INTERROGATION OF THE PATIENT THAT DAY. A SYSTEM DIAGNOSTICS TEST WAS PERFORMED WHICH SHOWED OUTPUT=LOW/CURRENT DELIVERED=0MA/LEAD IMPEDANCE=HIGH/IMPEDANCE VALUE #62;10,000OHMS/NEOS=NO. THE PHYSICIAN STATED THAT HE WASN'T SURE WHEN THE LAST DIAGNOSTICS WERE RUN BUT HE DID KNOW THAT WHEN HE INTERROGATED THE PATIENT'S DEVICE IN (B)(6) HE DID NOT RECEIVE A HIGH IMPEDANCE MESSAGE. THE PATIENT REPORTED SHE COULD PREVIOUSLY FEEL STIMULATION BUT HAS NOT BEEN ABLE TO FEEL THE NORMAL MODE STIMULATION FOR A COUPLE OF MONTHS NOW. THE PATIENT ALSO STATED THAT SHE HAS HAD AN INCREASE IN DEPRESSION, BELOW BASELINE, SINCE AROUND (B)(6) 2012. THE PATIENT STATES SHE HAS NOT EXPERIENCED ANY FALLS OR TRAUMA TO THE CHEST/NECK. THE PATIENT UNDERWENT BATTERY REPLACEMENT IN (B)(6) 2012, DUE TO END OF SERVICE. X-RAYS WERE RECEIVED FROM THE PHYSICIAN AND IT APPEARED THAT THE LEAD PIN WAS FULLY INSERTED INTO THE HEADER OF THE GENERATOR. A SMALL PORTION OF THE LEAD WAS BEHIND THE GENERATOR AND CONTINUITY IN THAT PORTION OF THE LEAD COULD NOT BE ASSESSED. BASED ON THE X-RAY IMAGES PROVIDED, NO CAUSE FOR THE REPORT OF HIGH IMPEDANCE COULD BE FOUND; HOWEVER, THE PRESENCE OF A MICRO-FRACTURE OR LEAD FRACTURE IN THE PORTION OF THE LEAD THAT COULD NOT BE ASSESSED CANNOT BE RULED OUT. THE PATIENT WAS SEEN FOR FOLLOW-UP ON (B)(6) 2012, AND DIAGNOSTICS CONTINUED TO SHOW HIGH IMPEDANCE. THE PHYSICIAN STATED THAT THIS IS CONSISTENT WITH A LEAD FRACTURE OR FAULTY LEAD AND NOT A GENERATOR FAILURE. THE PATIENT WAS REFERRED FOR SURGERY. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012, WHEN THE PHYSICIAN REPORTED THAT HE HAS BEEN TREATING THIS PATIENT FOR BIPOLAR II DISORDER FOR MANY YEARS AND SHE HAS A HISTORY OF SUICIDAL IDEATION WITH 3 PAST ATTEMPTS AND PSYCHIATRIC HOSPITALIZATIONS IN THE PAST. THE VNS, WHICH WAS IMPLANTED SEVERAL YEARS AGO, HAS BEEN VERY HELPFUL IN TERMS OF HER OVERALL MOOD STABILITY. WHEN THE PATIENT'S VNS WENT OUT ABOUT A YEAR AGO, SHE HAD A PERIOD OF DECOMPENSATION WHICH WAS VERY DIFFICULT TO CONTROL GIVEN HER LIMITED RESPONSE TO MEDICATIONS. THE PATIENT WAS NOTED TO HAVE MANIC SYMPTOMS WHEN GIVEN ANTIDEPRESSANTS AND HAS LIMITED RESPONSE TO THE MOOD STABILIZERS. THE PHYSICIAN WANTS THE PATIENT TO HAVE HER VNS RECONNECTED AS THIS HAS BEEN A MAINSTAY IN HER TREATMENT REGIMEN.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE VNS PATIENT HAD UNDERGONE A FULL REVISION SURGERY ON (B)(6), 2013. THE EXPLANTED PRODUCTS WERE RETURNED TO THE MANUFACTURER ON (B)(4) 2013 FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED. THE MANUFACTURING RECORDS FOR THE LEAD WERE REVIEWED; DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION.
ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ACCORDING TO THE INTERNAL IMPEDANCE CHECK, THE IMPEDANCE VALUE WENT FROM 2072 OHMS TO 12621 OHMS (HIGH IMPEDANCE) ON (B)(6) 2012. PRODUCT ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(6) 2013. PRODUCT ANALYSIS CONFIRMED DISCONTINUITY OF BOTH POSITIVE AND NEGATIVE QUADFILAR COILS IN THE ELECTRODE REGION OF THE RETURNED LEAD PORTIONS. THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS OF THE RETURNED 236 MM PORTION QUADFILAR COIL 1 AND QUADFILAR COIL 2 APPEARED TO BE BROKEN AT THE END OF THE ELECTRODE BIFURCATION. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON QUADFILAR COIL 1 COIL BREAK (FOUND AT END OF ELECTRODE BIFURCATION) AND IDENTIFIED THE AREA AS HAVING EXTENSIVE PITTING WITH MECHANICAL DAMAGE WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. PITTING WAS OBSERVED ON THE COIL SURFACE. SCANNING ELECTRON MICROSCOPY WAS PERFORMED QUADFILAR COIL 2 COIL BREAK (FOUND AT END OF ELECTRODE BIFURCATION) AND IDENTIFIED THE AREA ON THREE OF THE BROKEN COIL STRANDS AS BEING MECHANICALLY DAMAGED WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE AND NO PITTING. THE REMAINING BROKEN COIL STRAND WAS IDENTIFIED AS HAVING EVIDENCE OF A STRESS INDUCED FRACTURE WITH MECHANICAL DAMAGED AND NO PITTING. DETERMINATION COULD NOT CONCLUSIVELY BE MADE ON THE FRACTURE MECHANISM. PITTING WAS OBSERVED ON THE COIL SURFACE. IT IS BELIEVED THAT STIMULATION WAS PRESENT FOR A CERTAIN PERIOD OF TIME AS EVIDENCED BY THE PRESENCE OF METAL PITTING. LOW MAGNIFICATION SEM ANALYSIS OF THE QUADFILAR COIL SHOWS CHARACTERISTICS TYPICAL OF A LEAD DISCONTINUITY WHICH MAY INCLUDE: MATERIAL FRACTURE, ROUGH OR PITTED SURFACE, THINNED MATERIAL THICKNESS, ELECTRO-ETCHING OR MATERIAL DISSOLUTION. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITIES, THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED EXCEPT FOR THE SET OF SETSCREW MARKS FOUND NEAR THE END OF THE CONNECTOR PIN INDICATING THE LEAD HAD NOT BEEN FULLY INSERTED INTO THE CAVITY OF THE GENERATOR. THE ADDITIONAL SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LEAD MODEL 302 | LEAD | LYJ | CYBERONICS, INC. | 302-20 | 200354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |